Koroner arter bypass cerrahisi OFF/ON-pump revaskülarizasyon çalışması (Coronary trıal)
Özet
80 patients who matched the criteria were added to the study out of 540 patients who are enrolled with isolated coronary artery disease in Ankara University Cardiovascular Surgery Department. In this study, patient?s identity information and the planned procedure data were randomized using ROME web site. Primary goal of the study is to evaluate short and long term effectivity and safety of OPCAB in a wide, international, multi-centered and randomized controlled design. Addition of new centers to CORONARY TRIAL study in Turkey, was coordinated by our Cardiovascular Surgery Department. Whole-blood and biochemistry analyses, coagulation profiles, 12 derivation ECG and TTE were done for pre-operative evaluation. Median sternotomy were performed on all patients. Following randomization, 42 patients were operated by OFF-PUMP, ON-PUMP was used on 39 patients. Among 42 patients who enrolled OFF-pump coronary by-pass surgery, 3 were converted to ON-pump coronary surgery. Of these three patients, two had intramyocardial localization of LAD and the other patient was converted to ON-pump because of the hemodynamic unstability could not be achieved on the Cx artery position in OFF-pump settings. Two patients who were assigned to ON-pump group were converted to OFF-pump group, due to diffuse calcification in the ascending aorta which hinders aortic cannulation. LIMA was always preffered for arterial grafting, while saphenous vein grafts and, for suitable patients, radial graft counduit was prepared. Operative and post-operative variables were recorded for both groups of patients. ON-PUMP and OFF-PUMP patient groups showed no statistically significant difference in age, sex, CCS score, NYHA classification and EUROscore variables (p>0.05). Highest number of patients in NYHA classification, is class II (OFF-pump 68.8%, ON-pump 54.2%). A comparison between two groups regarding risk factors showed; there is no significant difference in the distribution of pulmonary artery hypertension, cerebro-vascular event, chronic kidney failure among groups (p>0.05), Diabetes Mellitus is significantly high in ON-PUMP group (%51.3, p < 0.05). In relation to revascularization, no significant difference (p=0.08) was observed in the number of arteries with atherosclerotic disease between OFF-pump (2.8 ± 0.7) and ON-pump (3.1 ± 0.7,). Postoperative evaluation showed significantly lower (p=0.01). duration for entubation in OFF-pump (6.1 ± 2.2 hours) patients compared to ON-pump patients(15.6±9.3 hours). OFF-pump group has lower need for postoperative inotropes (p=0.04). Between groups, while no significant difference is observed in duration of stay in ICU (p=0.3), OFF-pump group have significantly lower durations of hospital stay (p=0.01). In addition, OFF-pump group has significantly lower need for use of blood products (erythrocyte suspension, fresh frozen plasma and thrombocyte suspension). On pre-operative and post-operative lab results, ON-pump group has significant increase in post-operative CK-MB values. CORONARY TRIAL study, is an ongoing, extensive, world-wide project which is going to definitively resolve which technique is to be used on which type of patient. Surgical experience is of high necessity with OFF-pump surgery while, assisting surgical equipments gain importance as well. Post-operative data shows equally successful results with conventional method, especially achieving the complete revascularization. OFF-pump patients has shorter entubation and hospital stay duration. In addition, these patients has significantly lower requirements of erythrocyte suspension, fresh froozen plasma and thrombocyte suspension during ICU stay. Parallel to these results, significantly lower drainage amounts is recorded. Our study supports that, in experienced hands, OFF-pump surgery is a superior technique that has successful and safe results in complete revascularization and anostomosis compared to conventional surgery . We are confident that, with the completion of the multi-centered study, similar results are going to be announced. In conclusion, we believe that, CORONARY TRIAL study is going to complete the necessary missing information that were mentioned as shortcomings in conclusion and discussion parts of the retrospective and meta-analysis studies such as low patient number, lack of experienced surgical teams and long-term results, regarding OFF-pump coronary artery bypass surgery.